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Topical Salicylate Products for oral use in children
Notice type:
Advisory
Date:
23/04/2009
Product name or type:
Bonjela Oromucosal Gel, Teejel Gel
Problem Or Issue:
The Irish Medicines Board (IMB) is aware of the Medicines and Healthcare Products Regulatory Agency (MHRA) decision to restrict the use of salicylate containing products for oral use in children under 16. This decision has been taken following a risk/benefit review which was conducted following publication of a case report in June 2008, of a suspected but unconfirmed case of Reye’s syndrome associated with the use of an oral gel containing choline salicylate in a 20 month old child. The review concluded that the symptoms reported in the case report were not consistent with Reye’s syndrome and were more likely to reflect salicylate toxicity due to incorrect use of the gel.
The IMB states that following its own review, it is satisfied that the risk-benefit for the use of salicylate containing products in children is positive when used according to their approved conditions of use. The IMB will continue to monitor these products closely on the Irish market.
The IMB’s advice to parents and carers is that oral gels containing choline salicylate should be applied very sparingly and only at the frequency indicated in the product information. These products should only be used when clearly necessary and are intended for short-term use only.
The IMB states that at present there are two relevant products containing this active ingredient licensed in Ireland, Bonjela Oromucosal Gel and Teejel Gel. These products are licensed for use in children since 1983 for the treatment of infant teething. The IMB states that the risk associated with their short term use is extremely low and to date has received no reports of adverse reactions in children with these products. The risk of toxicity is associated with incorrect use or over-dosing.
The IMB wishes to emphasise that before any medicine is administered to a child, parents are advised to read the product information (labelling/patient information leaflet) carefully and consult with their doctor or pharmacist as appropriate. The IMB suggests that any parent or child minder, who has concerns or who requires further guidance on the correct use of these products, should contact their doctor or pharmacist.
ENDS
Background Information Or Related Documents:
Topical Salicylate Products for oral use in children Document
Further Information:
Siobhan Molloy / Angie Grant Tel: (01) 676 01 68 or
Weber Shandwick 086 817 5066 / 086 377 2791
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Date Printed: 16/04/2024